Junior Quality Specialist

il y a 3 semaines


Leuven, Belgique QAELUM Temps plein

We are currently looking for a junior Quality Specialist for our HQ in Belgium.

Qaelum NV is a fast-growing medical software solutions provider caring about patient safety, efficiency and quality improvements in medical imaging environments. With our solutions, we are one of the market leaders in Europe and have installations all over the globe. We believe it is our mission to help all stakeholders, no matter what level they are at, to creating patient safe and optimized healthcare environments. Have a look at our website and learn more about our solutions and company.

To support our growth and to strengthen our team we are currently looking for a **Jr Quality Specialist**.

Your responsibilities and tasks

You support Qaelum in the implementation and maintenance of our quality management systems and procedures and in ensuring compliance with regulatory requirements. We expect you to hold a relevant Master’s or Bachelor’s degree.
- You assist us in further developing and implementing quality management systems and processes in compliance with ISO13485 / ISO27001
- You maintain our quality management system according to the ISO13485 / ISO27001 requirements and our internal procedures
- You prepare and review documentation, including product documentation, procedures, work instructions and other quality related documents
- You participate in risk management activities and assist in developing risk management plans
- You assist in internal and external audits and inspections
- You provide support in handling quality-related customer requests and observed non-conformities
- You provide support in country-specific regulatory and quality pathways
- You have a strong attention to detail and organizational skills
- You are able to work in a small team and collaborate with cross-functional departments
- Experience in quality and regulatory for medical devices is a plus
- Knowledge of ISO13485 is a plus
- Knowledge of medical device software is a plus
- Knowledge of ISO27001 is a plus
- You preferably have a first good working experience in a medical device environment

You communicate fluently in **English**, both written and verbal (the knowledge of Dutch or other languages is a great asset) and love to learn and improve. What does it for us, is your drive and your intrinsic will to take initiative. The passion to ensure the safety of our patients by implementing well-controlled and maintained quality management systems and the willingness to learn and grow in the field of medical device quality/regulatory affairs are key criterions. We encourage a diverse environment where people are motivated to learn and to grow with the company. We hire people based on their skills and merit no matter their gender, age, location or background.

How we support you

We provide an internationally oriented working atmosphere in which a team of professionals is dedicated to improving quality in medical imaging environments. Together we build on the next generation of quality improvements in healthcare. You will enjoy the freedom and responsibilities that a young fast-growing company like ours can bring to the table. As we also attach great importance to a sound work-life balance and life-long learning, we provide flexible working hours, a home-office working balance, and every opportunity to take part in additional training courses in-house or elsewhere. Your main working place will be in our offices in **Leuven, Belgium (incl. flexible home-officing) but your contacts are worldwide**. Next to this you can count on a comprehensive and market conform remuneration package including extra-legal benefits. We offer a full-time permanent position.

**APPLY


  • Junior Quality Specialist

    il y a 4 semaines


    Leuven, Belgique AB InBev Temps plein

    Seniority Level: Mid-Senior Level Taakomschrijving: - Hij/zij draagt mede zorg voor de implementatie van de VPO-Quality Pillar en van hygiëne-, kwaliteits - en voedselveiligheidsaangelegenheden en dit in nauwe samenwerking met de diverse afdelingen en ZBS diensten. - Hij/zij voert audits uit en stelt het interne audit-plan mee op (planning, uitvoering,...

  • Quality Systems Specialist

    il y a 1 semaine


    Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...

  • Qc Specialist

    il y a 4 semaines


    Leuven, Belgique Talentus Temps plein

    De **HR-experten** van** Talentus** brengen jou in contact met je toekomstige werkgever. Deze gepassioneerde specialisten werken voor middelgrote Belgische ondernemingen. Zij maken er hun missie van om** jouw talent** te laten openbloeien in een job die je als gegoten zit. **Functie**: Als **QC Specialist** krijg je heel wat verantwoordelijkheden: - Als QC...


  • Leuven, Belgique In4Matic Temps plein

    **Function**: We're on the lookout for a seasoned SharePoint Specialist to join our client's team. This role is pivotal for individuals passionate about leading the charge in SharePoint design and development, ensuring seamless integration and security across various platforms. You'll orchestrate the concept creation, meticulous planning, and flawless...

  • CRM Specialist

    il y a 5 jours


    Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...

  • Customer Service Specialist

    il y a 3 semaines


    Leuven, Belgique Page Personnel Temps plein

    The main tasks and responsibilities for a Customer Service Specialist focusing on the DACH market:Manage and process customer orders for medical products with a focus on the DACH market (Germany, Austria, Switzerland).Provide exceptional customer service to clients, ensuring their inquiries and concerns are addressed promptly and accurately.Collaborate with...

  • Junior IC Layout Engineer

    il y a 3 semaines


    Leuven, Belgique ICsense NV Temps plein

    The job location can be Leuven or Ghent. The junior IC Layout Engineer is responsible for converting an electrical design to a mask layout used for chip fabrication. He is responsible for the physical representation of dedicated blocks of the chip. This will be done in close collaboration with the circuit designers and senior layout engineers. ...

  • Product Stewardship

    il y a 3 semaines


    Leuven, Belgique JSR Micro NV Temps plein

    Product Stewardship (Sr) Specialist Who are we? JSR Micro NV is part of the Japanese multinational JSR Corporation, which employs 8000 people worldwide in the chemical and life science sector. We are located in Leuven since 1988 and employ 230 people. JSR Micro NV produces state-of-the-art photoresists for the semiconductor industry that are...

  • Review Specialist Gmp

    il y a 4 semaines


    Leuven, Belgique Oxford Global Resources Temps plein

    **Review specialist GMP**: - Location: Leuven - Contact: Thomas De Naegel - Job type: Temp to Perm - Contact phone: +32 15284045 - Industry: Biotechnology Are you interested in GMP legislation and QA? **Function** The Review Specialist position is responsible for handling pre-manufacturing reviews, post-manufacturing reviews and GMP administration....

  • Chemical Specialist Glass

    il y a 4 jours


    Leuven, Belgique Oxford Global Resources Temps plein

    Location: Leuven - Contact: Morgane Tordeur - Job type: Permanent - Contact phone: +32 (0)15 858 039 - Industry: Food and Beverages Join our dynamic packaging team as a Chemical Specialist Glass Packaging and play a pivotal role in revolutionizing the glass packaging technologies at our client in Leuven. **Job description** You'll lead global projects...


  • Leuven, Belgique Vlerick Business School Temps plein

    **Would you like to contribute to the personal and professional learning journey of young graduates before they start their career? Do you love organising and taking part in various events? Does interacting and connecting with young people give you a boost and is solving problems your cup of tea? **Let’s talk!** **Junior Programme Manager...

  • Operations Specialist

    il y a 4 jours


    Leuven, Belgique Mega Group International S.A. Temps plein

    Our team is looking for a passionate Operations Specialist, **willing to help launch a new division inside the Mega Group**, grow its customer base and to reach 5* service. Hands-on, problem-solving, with passion for the Telecom market? Motivated to evolve within a fast-growing group? Apply! **The job**: In this role you will report to the Managing...

  • Tender & Contract Specialist

    il y a 1 semaine


    Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...

  • Global Yeast

    il y a 3 semaines


    Leuven, Belgique AB InBev Temps plein

    Seniority Level: The role: Support and lead R&D / Front-End-Innovation (FEI) projects (lab, pilot, and industrial scale) in GITEC and for the different AB InBev Zones according to the company priorities. Support and lead implementation projects in key AB InBev Zones and provide hands-on technical support. Execute and support projects according to...


  • Leuven, Belgique Terumo Temps plein

    Job Summary You will be located in our European Distribution Center (EDC) in Genk. As part of the Terumo EDC Supply Chain team, the main responsibility of the Warehouse Operations Specialist is a pivotal role responsible for ensuring the smooth operation and continuous improvement of our warehouse activities. This individual will have diverse...

  • Senior Structural Engineer

    il y a 3 semaines


    Leuven, Belgique Michael Page Temps plein

    Design and develop steel frame and offsite construction products, maintaining high standards of quality and efficiency.Research and innovate in the design process, seeking continuous improvement.Collaborate with diverse teams to enhance material production and assembly processes.Utilize advanced design software for detailed specifications and...

  • Senior Digital Design Engineer

    il y a 3 semaines


    Leuven, Belgique ICsense NV Temps plein

    The job location can be Leuven or Ghent. The Senior Digital Design Engineer is responsible for the study, design and verification of high quality ICs, technical team lead in challenging projects and the coaching of junior engineers. Responsibilities Study, specification, design and verification of high-quality digital and mixed-signal ICs ...


  • Leuven, Belgique Pauwels Consulting Temps plein

    -leuven bediende, freelancer 40 uur per week - David Prosku AliredzajTalent Acquisition Specialist IT 0032491622330 - **Senior Application Architect (AWS)**: ICT & Digital - Development Main tasks: - Identify and propagate reusable components when modeling data - Collaborate with architects, database designers, and development teams - Referentienummer...

  • Project Manager

    il y a 3 semaines


    Leuven, Belgique Septentrio N.V. Temps plein

    For our Leuven offices, we are looking for highly qualified and motivated professionals like you. If you think you have what it takes to keep Septentrio firmly in Pole Position, get in touch. We need you for the position of NPI Test Engineer The Job In collaboration with R&D, our NPI Test Engineer is responsible for developing and supporting...


  • Leuven, Belgique Datadobi Temps plein

    -Location: Leuven, Belgium No relocation package. Job description A System Administrator will focus on keeping our in-house and cloud technical environments current and in line with our changing business needs. You will maintain and administer the equipment in our datacenter, act as the technical contact to our different cloud-based platform suppliers and...